Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- intraoperative outcomes
研究概览
简要总结
Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. Recently, as the domestic surgical robot research project's main section, this new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University.
详细描述
One surgeon perform these surgical trials using the robot "Micro Hand S". All of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. In addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively
- •18years<age<65years
- •male or female
排除标准
- •patients with a history of open abdominal surgery
- •unstable psychiatric illness
- •an inability or reluctance to cooperate during long-term follow-up
- •alcohol or drug addiction
- •or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study
结局指标
主要结局
intraoperative outcomes
时间窗: up to 1 week after operation
surgical procedure/operative time/console time/blood loss/conversion
postoperative outcomes
时间窗: up to 1 month after operation
Time to first flatus/intake/hospital stay
complication
时间窗: within 30 days after surgery
type of complication/grade of complication
pathological outcomes
时间窗: up to 1 month after operation
resection margin/harvested lymph node/mesorectal grade
次要结局
- recurrence(at least 12 months after operation)
- functional outcomes(at least12 months after operation)
- survival(at least 12 months yesra after operation)
- change of blood and biochemiacl(within 1 month after operation)